The Recruitment Problem

Is U.S. patient recruitment a losing proposition?

By Deborah Borfitz

Sept. 5, 2008 | The disconnect between U.S. investigators’ and potential patients’ reported interest in clinical research, and their referral and enrollment patterns was one of the topics of discussion in June at the Drug Information Association’s 44th Annual Meeting in Boston*. Contributing to the dialogue were Matthew Kibby, global operations leader at BBK Worldwide; David Zuckerman, president of Customized Improvement Strategies; and Kenneth Getz, senior research fellow at Tufts University’s Center for the Study of Drug Development and chairman of the non-profit Center for Information and Study on Clinical Research Participation (CISCRP).

All three had concrete suggestions for improving U.S. patient enrollment statistics, which Zuckerman views as a “symptom” of other trial-related problems such as poorly written protocols and a haphazard approach to site selection.

Getz agreed, suggesting the recruitment problem may in fact be a reflection of unrealistic timelines or a protocol that’s unfeasible. He noted that 70 to 80 percent of AIDS and pediatric cancer patients participate in clinical trials regularly, but recruitment and retention rates overall have never been lower. Close to one billion in marketing dollars will be spent trying to improve the situation.

Kibby declined to blame protocols, given that same-study enrollment figures are far better in other countries. The U.S. gets sites up and running four times faster than places like China and Brazil, he said, putting it “in the best position to do something about [low enrollment].”

Site-Specific ChangesSite selection could be improved by focusing on “last patient out” rather than “first patient in” so decisions are driven by knowledge, not the clock, said Zuckerman. More systematic, upfront planning could “easily” double the overall enrollment rate from 5 to 10 percent.

Identifying high-enrolling sites is a crapshoot “because of the commoditized way sponsors view and approach their relationship with sites,” said Getz. “The sites see no loyalty or continuity, so they’re scrambling from one trial to the next, often being handed protocols they really shouldn’t be doing.” Site performance might be enhanced if sponsors and clinical research organizations treated sites as “strategic assets,” rather than asking them to bid on unfinished protocols or to repeatedly sit through the same RFP process.

Kibby said sites need help recruiting more efficiently, including identifying and consenting patients. Money won’t necessarily buy “greater recruitment acumen,” and it may create ethical issues.

Medical HeroesWhat’s needed is “more prudent allocation of dollars we’re already spending” to include building and repairing public trust in the clinical trials enterprise, said Getz. “One area of increasing concern to me is the general lack of appreciation for the gift people make when they participate in a clinical trial. This has been going on unanswered by industry for a decade.”

Pop culture depicts study volunteers as people “willing to gamble with their lives, take a risk with professionals who can’t be trusted, [and] who are motivated by greed and corruption,” said Getz. “I see a huge need to correct that perception.”

CISCRP co-developed a public awareness campaign with Fast4wD Ogilvy, the study recruitment arm of international advertising and marketing firm Ogilvy & Mather, to address the problem.

The “Everyday Heroes” campaign depicts clinical trial volunteers as medical champions. The program—inclusive of five print ads, four radio spots, and one television spot—shows how people of different ages, races, and occupations can contribute to medical research, says Diane Simmons, president and CEO of CISCRP. A phone number (877-MED-HERO) and website where viewers can learn more about the clinical research process are also provided.

The campaign has been shown to improve patient enrollment rates by 38 percent or more in six markets where Eli Lilly recently test-marketed the multimedia program in conjunction with standard recruitment ads, in contrast to 12 other markets where only the recruitment ads were used, says Simmons. On the second go-round with another trial in the same markets, the response rate more than doubled.

Widespread public distrust of the research process has helped reduce trial participation to abysmal levels across most therapeutic categories. The intent of the Everyday Heroes campaign is to “reposition the way the world looks at [trial] volunteers,” says Simmons. “To really have impact, dissemination of the campaign must be on a national scale with over 120 million impressions per quarter, and that is dependent on contributions from all of the clinical research stakeholders—pharmaceutical companies, CROs [clinical research organizations], academic medical centers, government agencies, disease advocacy groups, hospitals, community health centers, and individual contributors.”

Education is the “important step before participation,” she continues. To that end, CISCRP has spent the past few years developing general educational brochures and customized versions of the same for African-American and Hispanic populations. Educational DVDs have also been produced, most recently disease-specific ones focused on conditions such as diabetes and cancer.

These educational tools are accessible via the CISCRP website, together with “101 facts and figures” about clinical research, says Simmons. The site will soon get a social networking component.

“With all of the information about clinical research that is available online, what the public wants most can be difficult to find,” says Simmons. These findings prompted the development of CISCRP’s free public service (www.SearchClinicalTrials.org). The listing currently pulls from multiple public registries and excludes duplicate entries. “It’s like the Google of clinical trials.” The service has about 250,000 unique users per year, which is expected to grow exponentially to better meet the need for trial volunteers.

Participation DayCISCRP has already gifted four U.S. cities—Boston, Indianapolis, Dallas, and Philadelphia—with an annual Aware-For-All Clinical Research Education Day, says Simmons. The event takes place on “neutral turf” and brings together all key stakeholders to raise public awareness of trials while helping professionals in the clinical research enterprise “look at the world through the public’s eyes.”

Invitations to attend come from dozens of organizational partners, such as churches and YMCAs, who CISCRP supplies with educational materials. Based on exit surveys, 75 percent of consumers are more willing to participate in trials after attending the program, says Simmons. “These are not recruitment fairs.” They “put a human face on the people who volunteer for clinical trials while increasing public understanding of the risks and benefits of participating.”

Simmons adds that this form of outreach is needed in many more communities. “It’s time to say ‘thank you’ to the millions of people globally who give the gift of participation each year, and to stay committed to educating, informing, and empowering the public about what it means to be an active participant in the clinical research process.”